JanOne has completed a successful pre-IND meeting with the FDA regarding Jan123. Jan123 is the company's unique oral delivery of low dose naltrexone formulated to treat complex regional pain syndrome, an orphan disease of severe, debilitating impact. The Pre-IND meeting with the FDA produced a path toward formal drug application.

discussion topics included preclinical toxicology, CMC (Chemistry, Manufacturing and Control), pharmacokinetics, and clinical implementation. The agency's feedback will be used to move Jan123 toward a New Drug Application under a 505-b2 designation. Jan123 is a low dose naltrexone drug candidate that is ideally suited to treat complex regional pain syndrome.

It is a unique oral biphasic release tablet that has demonstrated ability to facilitate delivery of the medication to obtain maximum therapeutic benefit. JanOne CEO Tony Isaac noted that Jan123 is one of two late-stage innovative therapies for pain management developed by JanOne.